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不同微生物對消毒劑的抗性也各不相同。它們的順序從大到小的排列如下：
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Type of microorganisms 微生物種類 |
examples 實例 |
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Bacterial spores 細菌芽孢 |
Bacillus subtilis and clostridium sporogenes 枯草杆菌，產孢梭菌 |
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Mycobacteria 分枝杆菌 |
Mycobacterium tuberculosis 結核分枝杆菌 |
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Nonlipid-coated viruses 親脂病毒 |
Poliovirus and rhinovirus 脊髓灰質病毒，鼻病毒 |
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Fungal spores and vegetative molds and yeast 真菌孢子，生長態的黴菌與酵母菌 |
Trichophyton, cryptococcus, and Candida spp 發蘚菌，隱球菌屬，念珠菌屬等 |
|
Vegetative bacteria 生長態的細菌 |
Pseudomonas aeruginosa, Staphylococcus Aureus, and salmonella spp 綠膿杆菌，金色葡萄球菌，和沙門氏菌等等 |
|
Lipid-coated viruses 親水病毒 |
herpes simplex virus, hepatitis B virus, and human immunodeficiency virus 單純性皰疹病毒，乙肝病毒，人體免疫缺陷病毒 |
化學消毒劑按他們的化學型分類。其中包括醛，醇，鹵素，過氧化物，季胺類化合物，和酚類化合物。
|
Chemical entity 化學體 |
Classification 分類 |
Example 例證 |
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Aldehydes醛 |
sporicidal agent 殺孢子劑 |
2% glutaldehyde |
|
Alcohols醇 |
General purpose disinfectant, antiseptic, Antiviral agent， 一般用途的消毒劑，抗菌劑和抗病毒試劑 |
70% isopropyl alcohol, 70% alcohol, 70％的異丙醇，70%的乙醇 |
|
Chlorine and Sodium Hypochlorite 氯和次氯酸鈉 |
sporicidal agent 殺孢子劑 |
0.5% sodium hypochlorite 0.5％次氯酸鈉 |
|
Phenolics 酚類化合物 |
general purpose Disinfectant 一般用途的消毒劑 |
50μg per g chlorocresol, 500μg per g chloroxylenol 50μg/g 氯甲酚，500μg/g對氯間二甲酚 |
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Ozone 臭氧 |
sporicidal agent 殺孢子劑 |
8%gas by weight 8％的氣體（重量百分比） |
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Hydrogen Peroxide 過氧化氫 |
vapor phase sterilant, liquid Sporicidal Agent, antiseptic 蒸汽的殺菌劑，液體殺孢子劑，抗菌劑 |
4μg per g H2O2 vapor, 10%-25% solution, 3% solution 4μg/g 雙氧水蒸汽，10％－25%溶液，3％溶液 |
|
Substituted diguanides取代的二甲雙胍 |
antiseptic agent 抗菌劑 |
0.5% chlorhexidine gluconate 0.5％葡萄糖酸洗必太 |
|
Peracetic acid 過氧乙酸 |
liquid sterilant, Vapor phase Sterilant 液體殺菌劑，蒸汽的殺菌劑 |
0.2%peracetic acid, 1 μg per g peracetic acid 0.2％peracetic酸，1 μg/g過氧乙酸 |
|
Ethylene oxide 環氧乙烷 |
vapor-phase Sterilant 蒸汽的殺菌劑 |
600 μg per g ethylene oxide 600μg/g 環氧乙烷 |
|
Quaternary Ammonium Compounds 季氨鹽化合物 |
general purpose disinfectant, antiseptic 一般用途的消毒殺菌劑，抗菌劑 |
200 μg per g benzalkonium chloride 200 μg/g潔爾滅氯化物 |
|
β－propiolactone β－丙內酯 |
sporicidal agent殺孢子劑 |
100μg per g β-propiolactone β－丙內酯 |
抗微生物化學試劑可分為三類：殺菌劑，消毒劑和殺孢子劑。這裏列出的是通常與每個類別相關聯的試劑類型。
殺菌劑
由於蒸發快、殘留低的特點，消毒已被帶入APA的物品時應使用醇類（即異丙醇和乙醇）化學試劑。除非與材料存在相容性問題，應使用70％異丙醇（IPA）代替70％乙醇（ EtOH），因yin為wei異yi丙bing醇chun的de殺sha菌jun作zuo用yong被bei認ren為wei比bi乙yi醇chun稍shao大da。雖sui然ran醇chun類lei對dui活huo細xi胞bao具ju有you相xiang對dui較jiao好hao的de殺sha菌jun活huo性xing，但dan醇chun類lei的de快kuai速su揮hui發fa顯xian著zhu降jiang低di了le其qi效xiao力li。醇chun類lei殺sha菌jun劑ji對dui孢bao子zi無wu效xiao。
消毒劑
酚fen類lei和he季ji銨an化hua合he物wu對dui活huo細xi胞bao具ju有you廣guang譜pu殺sha菌jun活huo性xing。這zhe些xie化hua學xue物wu質zhi典dian型xing特te征zheng會hui帶dai來lai表biao麵mian殘can留liu。緊jin隨sui它ta們men的de使shi用yong應ying清qing除chu該gai部bu分fen殘can留liu，例li如ru通tong過guo異yi丙bing醇chun擦ca拭shi清qing除chu。
殺孢子劑
次氯酸鈉（漂白劑）和過氧化氫/過氧乙酸化合物是廣泛使用的殺孢子劑。過氧化氫也可用於（通常在6％濃度）提(ti)供(gong)對(dui)黴(mei)菌(jun)和(he)一(yi)些(xie)孢(bao)子(zi)形(xing)式(shi)微(wei)生(sheng)物(wu)提(ti)供(gong)抗(kang)菌(jun)活(huo)性(xing)。過(guo)氧(yang)化(hua)物(wu)比(bi)醇(chun)類(lei)抗(kang)菌(jun)活(huo)性(xing)更(geng)高(gao)，分(fen)解(jie)後(hou)形(xing)成(cheng)水(shui)和(he)氧(yang)氣(qi)，不(bu)產(chan)生(sheng)留(liu)殘(can)。當(dang)消(xiao)毒(du)程(cheng)序(xu)要(yao)求(qiu)清(qing)除(chu)孢(bao)子(zi)類(lei)微(wei)生(sheng)物(wu)時(shi)應(ying)采(cai)用(yong)化(hua)學(xue)殺(sha)孢(bao)子(zi)劑(ji)。不(bu)幸(xing)的(de)是(shi)，除(chu)過(guo)氧(yang)化(hua)氫(qing)外(wai)這(zhe)些(xie)化(hua)學(xue)品(pin)均(jun)有(you)一(yi)定(ding)殘(can)留(liu)。
以下列出了一些具有代表性的消毒劑的活性的作用位置和作用方式：
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Target 目標 |
Disinfectant 消毒劑 |
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Cell wall 細胞壁 |
Formaldehyde, hypochlorite, and mercurials 甲醛，次氯酸鹽，汞製劑 |
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Cytoplasmic membrane, action on membrane potential 細胞膜，膜電位作用 |
Anilides and hexachlorophene 苯氨，六氯酚 |
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Membrane enzymes, action on electrontransport chain 糖皮質激素酶，電子轉移作用 |
Hexachlorophene 六氯酚 |
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Action on ATP 三磷酸腺苷作用 |
Chlorhexidine and ethylene oxide 氯己定和環氧乙烷 |
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Action on enzymes with –SH groups 巰基酶作用 |
Ethylene oxide, glutaraldehyde, hydrogen peroxide, hypochlorite, iodine, and mercurials 環氧乙烷，戊二醛，過氧化氫，次氯酸鹽，碘，汞製劑 |
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Action on general membrane permeability 一般膜滲透性作用 |
Alcohols, chlorhexidine, and quaternary ammonium compounds 乙醇，氯己定，季胺類化合物 |
|
Cell contents, general coagulation 細胞內含物，一般凝固 |
Chlorhexidine, aldehydes, hexachlorophene, and quaternary ammonium compounds 氯己定，醛，六氯酚，季胺類化合物 |
|
Ribosomes 核糖體 |
Hydrogen peroxide and mercurials 過氧化氫和汞製劑 |
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Nucleic acids 核酸 |
Hypochlorites 次氯酸鹽 |
|
Thiol groups 巰基 |
Ethylene oxide, glutaraldehyde, hydrogen peroxide, hypochlorite, mercurials 環氧乙烷，戊二醛，過氧化氫，次氯酸鹽，汞製劑 |
|
Amino groups 氨基 |
Ethylene oxide, glutaraldehyde, and hypochlorite 環氧乙烷，戊二醛，次氯酸鹽 |
|
General oxidation 一般氧化 |
Ethylene oxide, glutaraldehyde, and hypochlorite 環氧乙烷，戊二醛，次氯酸鹽 |
New suppliers and new antimicrobial chemical agents for use in the disinfection program should be qualified prior to use following established procedures. A satisfactory audit, qualification testing, and a clearly defined
Certificate of Analysis (CoA) are important aspects to be considered as part of the qualification. If changes occur in the agent\'s formulation, packaging, or manufacturing site, an evaluation should be performed to determine if requalification is required.
用於消毒程序的新的供應商和新的殺菌化學試劑應在使用前根據建立的程序進行確認。令人滿意的審計、確認測試和清楚定義的檢驗報告（ COA）被認為是確認中的重要部分。如果試劑的配方、包裝或生產場所有所變更，則應進行評估以確定是否需要重新確認。
When choosing a new antimicrobial chemical agent from a supplier, evaluate the supplier\'s:
在從一個供應商處選擇一個新的殺菌化學試劑時，要評估供應商的：
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Product literature/technical data
產品文字/技術數據 -
Material safety information
物料安全信息 -
Material compatibility
物料相容性 -
Compatibility information
相容性信息 -
Storage conditions
存貯條件 -
Packaging presentations
包裝 -
Expiring dating
有效期 -
Disposal requirements
處理要求 -
Efficacy data
有效性數據 -
Sterility and sterilization information (if the product is provided sterile)
無菌和滅菌信息（如果產品是作為無菌產品）
In evaluating supplier information related to the efficacy of an antimicrobial chemical agent, it is important to understand the testing methodology and standards used. These often vary depending on where the agent was registered and the claims made regarding its use.
zaipingguguanyushajunhuaxueshijiyouxiaoxingdegongyingshangxinxishi，lejiesuoyongdeceshifangfahebiaozhunfeichangzhongyao。zhexietongchanggenjushijizhucedibutong，yijiguanyuqiyongtudeshengmingeryouchayi。
Depending on the specific use of the antimicrobial chemical agent and experience with the specific supplier, an audit may need to be performed. Extra attention should be given to the following during an audit:
根據殺菌化學試劑的特定用途和特定供應商的經驗，可能需要進行審計。在審計中需要注意以下方麵：
Environmental control and cleaning of the manufacturing or packaging area and equipment used to manufacture the antimicrobial chemical agent.
用於生產殺菌化學試劑的生產或包裝區域和設備的環境控製和清潔
Control and disinfection or sterilization of the antimicrobial chemical agent packaging containers.
殺菌化學試劑包裝容器的控製和消毒或滅菌
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Documentation and review of antimicrobial chemical agent production processing activities.
殺菌化學試劑生產處理活動的文件記錄和審核 -
For aseptically filled agents, the environmental monitoring (EM) program data, including alert and action levels, trending, corrective actions taken, and the use of neutralizing agents for the EM media used.
對於無菌灌裝試劑，環境監測（ EM）程序數據，包括警戒限和行動限、趨勢、所采取的糾正措施以及所用EM培養基的中和劑使用 -
For agents labeled as sterile, sterility testing data and qualification of the sterilization process.
對於標識為無菌的試劑，無菌測試數據和無菌工藝確認 -
Water systems and the quality of water used in the manufacturing process.
水係統和工藝用水的質量 -
Package or container integrity studies.
包裝或容器完整性研究 -
For double- and triple-bagged containers, disinfection of filled container and overwrapping integrity.
對於雙層或三層袋裝容器，灌裝容器消毒和外包裝完整性 -
For double- and triple-bagged containers where a claim of sterility is made for inner bags, qualification of the sterilization process used.
對於雙層和三層袋裝容器，如果內袋有無菌聲明，所用的滅菌過程的確認 -
Handling and storage of finished product containers or work in progress.
成品容器或中間產品的處理和存貯 -
Study results to support label claim of agent.
支持試劑標簽聲明的研究結果 -
Documentation related to regulatory approval of agent.
與試劑法規批準有關的文件記錄 -
Change control: customer notification of ingredient changes or process changes that would affect the finished product—for example, wrapping, irradiation, and sterilization.
變更控製：會影響成品，例如，包裝、輻射和滅菌，的成分變更或工藝變更時對客戶的通知
Qualification testing of a new antimicrobial chemical agent should include both laboratory and insitu testing. Chemical analysis of the actives and microbial efficacy testing should be performed.
對一個新的抗菌化學試劑的確認測試應包括化驗室和現場測試。要進行活性化學分析以及微生物有效性測試。
Chemical analysis of the actives may be provided by the vendor or, alternatively, performed in-house or by a qualified contract laboratory using the vendor\'s method. Microbial efficacy testing, whether in suspension or in
carrier studies, should be performed in-house or by a qualified contract testing laboratory.
活huo性xing化hua學xue分fen析xi可ke以yi由you供gong應ying商shang提ti供gong，或huo者zhe內nei部bu測ce試shi，或huo由you一yi個ge經jing過guo確que認ren的de合he同tong化hua驗yan室shi使shi用yong供gong應ying商shang的de方fang法fa進jin行xing測ce試shi。微wei生sheng物wu有you效xiao性xing試shi驗yan，如ru果guo是shi在zai混hun懸xuan液ye中zhong或huo在zai載zai體ti研yan究jiu中zhong，應ying內nei部bu進jin行xing測ce試shi，或huo由you經jing過guo確que認ren的de第di三san方fang化hua驗yan室shi進jin行xing測ce試shi。
The antimicrobials chemical agents used for testing should be close to or beyond their stated in-use expiration date (this should take into account a ready to use and/or a use dilution prepared from a concentrate expiry). Testing should be done in replicate on multiple lots of the antimicrobial chemical agent where applicable. It should be noted that significant registration testing on multiple lots of the agent is performed by the company registering the product to ensure product consistency between lots and stability throughout the stated shelf life.
用於測試的抗菌化學試劑應鄰近或超出其使用有效期（這裏要考慮直接使用和/或稀釋使用時濃縮液的有效期）。如ru果guo可ke以yi的de話hua，應ying對dui多duo個ge批pi次ci進jin行xing平ping行xing測ce試shi。要yao注zhu意yi的de是shi對dui多duo批pi試shi劑ji的de重zhong要yao的de注zhu冊ce測ce試shi是shi由you注zhu冊ce公gong司si來lai進jin行xing的de，以yi確que保bao產chan品pin不bu同tong批pi次ci之zhi間jian的de一yi致zhi性xing，以yi及ji其qi所suo聲sheng明ming的de整zheng個ge貨huo架jia期qi的de穩wen定ding性xing。
Additional qualification may be performed if changes in product formulation or packaging or site investigations deem it necessary. Information supporting the qualification includes the following seven areas:
如果生產配方或包裝進行了變更，或現場調查認為必要時，可能需要進行再次確認。支持確認的信息包括以下七個方麵：
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Description of packaging, label, and container type
包裝、標簽和容器類型描述 -
Description of ingredients and concentrations
成分和濃度描述 -
Lot or batch number
批號 -
Efficacy testing results
有效性測試結果 -
Irradiation or other sterilization verification certification
輻射或其它滅菌確認認證 -
Safety data sheet information
安全數據信息表
-
Disposal information
處理信息
Efficacy Testing
有效性測試
The demonstration of antimicrobial chemical agents to provide their respective kills is a function of the concentration of microorganisms present, the type of microorganisms, the choice of agent, the concentration of the agent, the porosity or texture of the surface to be cleaned, the method of application, and the contact time.Routinely, the agent used should be effective against the normal microbial vegetative flora recovered from the facility. Many efficacy testing guidelines, such as the Association of Official Analytical Chemist (AOAC), suggest high microorganism inoculum levels requiring longer contact times to destroy the population of cells . As the normal clean room bioburden level is very low, the inoculum levels for testing would ideally depict levels seen in the controlled area. As this would not be practical in a test environment ahigher inoculum level should be used and should not exceed 105. The antimicrobial chemical agent used within the industry can be broken into three general areas: sanitizers, disinfectants, and sporicides.
抗菌化學試劑殺滅效果是被殺滅微生物濃度、微生物類型、試劑選擇、試劑濃度、要清潔的表麵的孔隙度或質地、所(suo)使(shi)用(yong)的(de)方(fang)法(fa)以(yi)及(ji)接(jie)觸(chu)時(shi)長(chang)的(de)函(han)數(shu)。一(yi)般(ban)來(lai)說(shuo)，所(suo)用(yong)的(de)試(shi)劑(ji)應(ying)對(dui)從(cong)設(she)施(shi)中(zhong)回(hui)收(shou)到(dao)的(de)常(chang)規(gui)微(wei)生(sheng)物(wu)植(zhi)物(wu)群(qun)落(luo)有(you)效(xiao)。許(xu)多(duo)有(you)效(xiao)性(xing)測(ce)試(shi)指(zhi)南(nan)，例(li)如(ru)美(mei)國(guo)分(fen)析(xi)化(hua)學(xue)家(jia)協(xie)會(hui)（ AOAC），建(jian)議(yi)高(gao)濃(nong)度(du)微(wei)生(sheng)物(wu)接(jie)種(zhong)需(xu)要(yao)更(geng)長(chang)的(de)接(jie)觸(chu)時(shi)長(chang)以(yi)摧(cui)毀(hui)細(xi)胞(bao)群(qun)。由(you)於(yu)常(chang)規(gui)潔(jie)淨(jing)間(jian)生(sheng)物(wu)負(fu)載(zai)水(shui)平(ping)非(fei)常(chang)之(zhi)低(di)，測(ce)試(shi)的(de)接(jie)種(zhong)水(shui)平(ping)理(li)想(xiang)地(di)描(miao)述(shu)了(le)受(shou)控(kong)區(qu)域(yu)所(suo)見(jian)水(shui)平(ping)。由(you)於(yu)這(zhe)種(zhong)情(qing)況(kuang)在(zai)測(ce)試(shi)環(huan)境(jing)中(zhong)不(bu)現(xian)實(shi)，需(xu)要(yao)使(shi)用(yong)更(geng)高(gao)的(de)接(jie)種(zhong)水(shui)平(ping)，應(ying)超(chao)出(chu)105。行業內所用的抗菌化學試劑可以分為三個常規區域：滅菌劑、消毒劑和殺孢子劑。
Sanitizers
滅菌劑
Sanitizers provide minimal reduction in thirty seconds to ten minutes and are often used for low levels of vegetative microorganisms. The type of sanitizer will dictate the appropriate contact time required. Alcohol is an example of a commonly used sanitizer.
殺菌劑提供在30秒到10分鍾最小減少量，通常用於低水平的植物性微生物。滅菌劑的類型決定了所需適當的接觸時長。乙醇是常用的滅菌劑的例子。
Disinfectants
消毒劑
Disinfectants exhibit a higher level of efficacy than sanitizers, and their kill is dependent on the inoculums and the contact time. Disinfectants will typically kill vegetative microorganisms with the exception of spore-forming microorganisms. Examples include quaternary ammonium compounds and phenolics.
消xiao毒du劑ji比bi滅mie菌jun劑ji具ju有you更geng高gao的de有you效xiao性xing，其qi殺sha滅mie性xing與yu接jie種zhong水shui平ping和he接jie觸chu時shi長chang無wu關guan。消xiao毒du劑ji一yi般ban會hui殺sha滅mie植zhi物wu性xing微wei生sheng物wu，孢bao子zi形xing態tai除chu外wai。消xiao毒du劑ji例li子zi包bao括kuo季ji胺an鹽yan和he酚fen醛quan物wu。
Sporicides
殺孢子劑
Sporicides provide up to a total kill depending on the inoculums and the wet contact time and will kill bacterial spore formers as well as mold. Products commonly used today include bleach, hydrogen peroxide, and a mixture of hydrogen peroxide and peracetic acid.
殺孢子劑提供全麵殺滅性，其殺滅能力與接種水平、濕潤接觸時長有關，能殺滅細菌孢子形態以及黴菌。現今常用產品包括漂白劑、過氧化氫、過氧化氫和過氧乙酸混合物。
In general, contact or dry times in qualification studies should not exceed 120 seconds for alcohols (70% isopropanol and 70% denatured ethanol) and 10 minutes for disinfectants and sporicides. Longer contact times may be required based on the specific chemical agents used.
一般來說，在確認研究中接觸時長或幹燥時長，乙醇（ 70%異丙醇，和70%變性乙醇）應超過120秒鍾，消毒劑和殺孢子劑應超過10分鍾。如果所用的是特定的化學試劑，可能需要更長的接觸時長。
Methods to demonstrate efficacy include in-suspension and surface carrier (coupon) studies. In general, a total of three antimicrobial chemical agents (sanitizer, disinfectant, or sporicide) are all that would be qualified within the typical biopharmaceutical or pharmaceutical facility. While historically it was thought that a wide array of disinfectants were required to minimize the buildup of facilityresistant microorganisms, this is no longer a widely
held belief.
證明有效性的方法包括懸浮液和表麵載體（樣本）研究。一般來說，三種抗菌化學試劑（殺菌劑、消毒劑或殺孢子劑）的(de)總(zong)合(he)都(dou)要(yao)在(zai)典(dian)型(xing)的(de)生(sheng)物(wu)藥(yao)品(pin)或(huo)藥(yao)品(pin)設(she)施(shi)裏(li)進(jin)行(xing)確(que)認(ren)。曆(li)史(shi)上(shang)曾(zeng)經(jing)有(you)過(guo)想(xiang)法(fa)需(xu)要(yao)寬(kuan)範(fan)圍(wei)的(de)消(xiao)毒(du)劑(ji)來(lai)最(zui)大(da)程(cheng)度(du)減(jian)少(shao)設(she)施(shi)耐(nai)藥(yao)菌(jun)的(de)累(lei)積(ji)，但(dan)現(xian)在(zai)這(zhe)種(zhong)想(xiang)法(fa)已(yi)不(bu)再(zai)廣(guang)泛(fan)流(liu)行(xing)了(le)。
